ADVANCED FLUORIDE ANTICAVITY- sodium monofluorophosphate paste, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Personal Care Products, LLC

INN (International Name):

SODIUM MONOFLUOROPHOSPHATE

Composition:

SODIUM MONOFLUOROPHOSPHATE 0.76 g in 100 g

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Anticavity toothpaste Use Aids in the prevention of cavities

Authorization status:

OTC monograph final

Summary of Product characteristics

ADVANCED FLUORIDE ANTICAVITY - SODIUM MONOFLUOROPHOSPHATE PASTE,
DENTIFRICE
PERSONAL CARE PRODUCTS, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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ADVANCED FLUORIDE ANTICAVITY TOOTHPASTE
Active Ingredent
Sodium Monofluorophosphate 0.76%
Purpose
Anticavity toothpaste
Use
Aids in the prevention of cavities
If more than is used for brushing is accidentally swallowed get
medical help or contact a poison control
center right away.
Keep out of reach of children under 6 yrs of age.
Directions
adults and children 2 years. and older: brush teeth thoroughly after
meals or at least twice a day or as
directed by a dentist.
do not swallow
to minimize swallowing, use a pea-sized amount in children under 6
years old
supervise children's brushing until good habits are established
children under 2y ears: ask a dentist before use.
Inactive ingredients-
calcium carbonate, calcium hydrogen phosphate, carboxymethyl
cellulose, flavor, glycerin, hydrated
alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium
lauryl sulfate, sorbitan
monooleate, sorbitol, titanium dioxide, water, xanthan gum.
CAVITY FIGHTING TOOTHPASTE
Distributed by:
Personal Care Products, LLC
Bingham Farms, MI 48025-2463
Made in China
Advanced Fluoride Anticavity Toothpaste
New Ultra Breath Freshener Stripe
Net Wt 6.4oz (181g)
Multi
Protection
Fights Cavities
Freshens Breath
ADVANCED FLUORIDE ANTICAVITY
sodium monofluorophosphate paste, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:29 50 0 -0 8 19
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -
UNII:Q8 0 VPU40 8 O)
SODIUM
MONOFLUOROPHOSPHATE
0 .76 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)
ANHYDRO US DIBAS